Study of Current Practice Which Compare the Rate of Prostate Cancer by Using 2 Kind of Transrectal Biopsies: 3 by IRM-echography Image Fusion and 12 Systematized Guided Echographies.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-02-28

Brief Summary

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The purpose of the study is to show that 3 targeted biopsies on the suspicious image detected by IRM, guided by a fusion of MRI and ultrasound- images with the Koelis ® system, will get no lower rate of cancer detection than those obtained by 12 systematic transrectal ultrasound-guided biopsies of the prostate.

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Detailed Description

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The act of current practice evaluated by this research is the act of prostate biopsies : the patient will have to undergo 12 systematized transrectal echography guided biopsies of the prostate and 3 additional biopsies targeted on the suspicious lesion detected with MRI, which are both done in current practice.

* A first operator is not informed of the location of the target. He will perform a series of 12 systematic transrectal ultrasound-guided biopsies of the prostate.
* Immediately after the second operator will perform 3 additional targeted biopsies on the suspicious image detected by IRM, guided by a fusion of MRI and ultrasound- images with the Koelis ® system

Act added by the research: Using a fusion of MRI - ultrasound images software system (Koelis ®).

Conditions

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Prostate Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Targeted biopsies guided by a fusion of MRI and ultrasound

After the 12 systematic biopsies, the same patients will have to undergo 3 additional targeted biopsies on the suspicious image detected by IRM, guided by a fusion of MRI and ultrasound- images with the Koelis ® system

Group Type OTHER

systematic biopsies

Intervention Type PROCEDURE

90 patients will have to undergo 12 systematic transrectal ultrasound-guided biopsies of the prostate

Targeted biopsies guided by a fusion of MRI and ultrasound- images

Intervention Type PROCEDURE

Immediately after the 12 systematic biopsies, the same patients will have to undergo 3 additional targeted biopsies on the suspicious image detected by IRM, guided by a fusion of MRI and ultrasound- images with the Koelis ® system

Systematic biopsies

The patients will have to undergo 12 systematic transrectal ultrasound-guided biopsies of the prostate

Group Type OTHER

systematic biopsies

Intervention Type PROCEDURE

90 patients will have to undergo 12 systematic transrectal ultrasound-guided biopsies of the prostate

Targeted biopsies guided by a fusion of MRI and ultrasound- images

Intervention Type PROCEDURE

Immediately after the 12 systematic biopsies, the same patients will have to undergo 3 additional targeted biopsies on the suspicious image detected by IRM, guided by a fusion of MRI and ultrasound- images with the Koelis ® system

Interventions

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systematic biopsies

90 patients will have to undergo 12 systematic transrectal ultrasound-guided biopsies of the prostate

Intervention Type PROCEDURE

Targeted biopsies guided by a fusion of MRI and ultrasound- images

Immediately after the 12 systematic biopsies, the same patients will have to undergo 3 additional targeted biopsies on the suspicious image detected by IRM, guided by a fusion of MRI and ultrasound- images with the Koelis ® system

Intervention Type PROCEDURE

Other Intervention Names

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Ultrasound-guided biopsies of the prostate Biopsies of the prostate by fusion of MRI and ultrasound- images with the Koelis ® system

Eligibility Criteria

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Inclusion Criteria

* patient from 45 to 75 years old;
* Serum level of PSA \> 4,0 ng / mL;
* Multiparametric prostate IRM, performed before inclusion and which confirm the diagnosis of suspected target;
* No opposition of the patient notified in the medical record
* patient member in a national insurance scheme.

Exclusion Criteria

* Previous prostate biopsy;
* suspicious digital rectal examination;
* serum PSA \> 20,0 ng / mL;
* treatment with 5 alpha reductase inhibitor during the last 3 months;
* untreated urinary infection

Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No